Maintaining CE Compliance in Serial Production: Key Quality Control Steps

How is the CE Certificate Maintained During Serial Production Through Factory Production Controls and Quality Processes?

The CE Mark is not only valid for the first product but for all batches of serial production. The product must meet the same safety and performance requirements throughout its production. Therefore, once the CE certificate is obtained, it must be continuously monitored and controlled during the production process.

1. Is Getting the CE Certificate Enough?

No. The CE mark must demonstrate that the product complies with the regulations not only at the beginning but throughout the entire serial production process. Manufacturers must actively implement quality control and monitoring mechanisms to maintain this continuity.

2. What is Factory Production Control (FPC)?

Factory Production Control (FPC) is the quality system that ensures products are manufactured according to the same standards during serial production. It is mandatory for many product groups under European regulations.

Key Elements of FPC:

• Incoming raw material inspections
• Traceability during production stages
• Testing at critical stages
• Final product inspection lists
• Regular record-keeping and tracking

FPC is an integral part of the CE marking process, especially for products like construction materials, pressure equipment, and gas appliances.

3. Which Regulations Require Continuous Production Control?

Certain CE regulations require not only the initial type testing but also continuous monitoring during serial production:

• Construction Products Regulation (305/2011/EU – CPR)
• ATEX Directive (2014/34/EU)
• Gas Appliances Regulation (2016/426)
• Pressure Equipment Directive (2014/68/EU – PED)
• Medical Devices Regulation (MDR – 2017/745)

Under these regulations, manufacturers are obligated to demonstrate that their products meet the same conformity in every production batch, not just in the initial tests.

4. Common Mistakes in Serial Production

• Relying on the initial type test and neglecting production monitoring
• Failing to inspect parts from different suppliers
• Continuing to use the CE mark without updating technical files
• Not following updated EN standards

Such mistakes can lead to product recalls or administrative penalties for the manufacturer.

The CE Mark is essential for the safe circulation of your product in the European market. However, conformity is not a one-time process; it must be continuously maintained during serial production.

For more information, contact Sertifike.